Table 5.
Inhibitor | NCT number | Phase | Population | Treatment | Estimated enrollment | Primary outcome | Status |
---|---|---|---|---|---|---|---|
Afatinib | NCT03727724 (AFACET) | II | Advanced/metastatic NSCLC with EGFRex20ins | Afatinib 40 mg QD, cetuximab 500 mg/m2 iv Q2W | 37 | DCR | Recruiting |
NCT04206787(START) | NA | Advanced/metastatic NSCLC with EGFRm | Afatinib and 3rd generation EGFR TKI | 825 | TOT | Recruiting | |
NCT03810872 | II | Advanced/metastatic cancers harboring either an activating EGFR mutation or a HER2 mutation or a HER3 mutation | Afatinib 40 mg/day during Period 1 Afatinib 40 mg/day + Paclitaxel 80mg/kg/3w during Period 2 | 87 | ORR and Incidence and intensity of adverse events | Recruiting | |
Osimertinib | NCT03414814 (KCSG LU17-19) | II | Pretreated advanced/metastatic NSCLC with EGFRex20ins | Osimertinib 80 mg QD | 28 | ORR | Active, not recruiting |
NCT02496663 | I | Previously treated NSCLC with EGFR mutation including EGFRex20ins | Osimertinib 80 mg QD Necitumumab | 100 | Safety and tolerability | Recruiting | |
NCT02151981 | III | Locally advanced or metastatic NSCLC with T790M mutation | Osimertinib 80 mg QD | 419 | PFS | Recruiting | |
NCT04035486(FLAURA2) | III | Advanced/metastatic NSCLC with EGFR mutation | Osimertinib 80mg QD | 586 | PFS | Recruiting | |
NCT03460275 | II | Advanced/metastatic NSCLC with EGFR mutation | Osimertinib Mesylate Tablets 80 mg QD | 100 | RECIST | Recruiting | |
NCT03219970 | NA | Locally advanced or metastatic NSCLC with T790M mutation | Osimertinib 80mg QD | 156 | OS | Active, not recruiting | |
NCT03521154(LAURA) | III | Previously treated NSCLC with EGFR mutation | Osimertinib 80mg/40mg | 200 | PFS | Recruiting | |
NCT02442349(AURA17) | II | Previously treated NSCLC with EGFR mutation | Osimertinib 80mg QD | 171 | ORR | Recruiting | |
Avitinib | NCT03856697 | III | Advanced/metastatic NSCLC with EGFR mutation | Avitinib Maleate Capsules 300mg BID | 406 | PFS | Not yet recruiting |
NCT02274337 | I/II | Previously treated advanced/metastatic NSCLC with EGFR mutation | Avitinib QD different dose stage | 100 | Safety, tolerability and ORR | Not yet recruiting | |
Olmutinib (HM61713) | NCT02485652 | II | Previously treated NSCLC with EGFR T790M mutation | HM61713 800 mg QD | 162 | ORR | Active, not recruiting |
Poziotinib | NCT04044170 | II | Previously treated NSCLC with EGFRex20ins or HER2 ex20ins | Poziotinib orally | 114 | ORR | Active, not recruiting |
Mobocertinib (TAK-788) | NCT03807778 | I/II | Previously treated NSCLC with EGFRex20ins | TAK-788 40mg QD phase 1, TAK-788 160 mg QD phase 2 | 63 | ORR | Recruiting |
Pyrotinib | NCT04063462 | II | Previously treated NSCLC with EGFRex20ins or HER2 ex20ins | Pyrotinib 400 mg QD | 60 | ORR | Not yet recruiting |
NCT03574402 (TRUMP) | II | Arm9: NSCLC with EGFRex20ins | Pyrotinib either 60 mg QD or 40 mg BID | 400 | ORR | Recruiting | |
Tarloxotinib (TH-4000) | NCT03805841 (RAIN) | II | NSCLC with EGFR ex20ins or HER2 activating mutation | Tarloxotinib bromide | 60 | ORR | Recruiting |
DZD9008 | NCT03974022 | I/II | Advanced/metastatic NSCLC with EGFR/HER2 mutations | DZD9008 | 160 | ORR | Recruiting |
Lazertinib (YH25448) | NCT04248829 (Lazertinib) | III | Locally advanced or metastatic NSCLC with EGFR mutation | Lazertinib 240 mg/160 mg | 380 | PFS | Recruiting |
JNJ-61186372 | NCT04077463 | I/II | Previously treated NSCLC with EGFR mutation | Lazertinib and JNJ-61186372 | 120 | DLT and ORR | Recruiting |
NCT02609776 | I | Previously treated NSCLC with EGFR mutation | JNJ-61186372 140 mg | 460 | DLT and ORR | Recruiting |
NSCLC, non-small cell lung cancer; EGFR, epidermal growth factor receptor; Ex, exon; Ins, insertion; HER2, human epidermal growth factor receptor2; Mut, mutation; QD, once daily; BID, twice daily; DCR, disease control rate; ORR, objective response rate; OS, overall survival; PFS, progression free survival; RECIST, response evaluation criteria in solid tumors; TOT, time on treatment; DLT, dose limiting toxicity. NA, missing value.